ON 20TH MAY 2016, A NEW LAW CAME INTO EFFECT WITH HUGE IMPLICATIONS FOR THE ECIGARETTE INDUSTRY.

WE CAN HELP YOU UNDERSTAND WHAT THIS MEANS FOR YOU, AND WE CAN HELP YOU BE TPD COMPLIANT.

What is the TPD?

In 2014, the European Commission added electronic cigarettes into the Tobacco Products Directive and gave them their own article (Article 20) within the document which effectively classified them as a tobacco product.

This article outlines the requirements which must be met in order to manufacture and retail electronic cigarettes, refills, and associated accessories. The TPD has been written into UK law and is detailed in the Tobacco and Related Products Regulations 2016 (TRPR).

How To Become TPD Compliant

Pre-Acceptance Samples Submitted

TPD Samples submitted

Analysis

Flavour Modification in Flavour Laboratory

Comparison to Toxicological Data

Flavour Modification in Flavour Laboratory

If the comparison with the Toxicological Data fails in Step 4, then the flavour is modified and analysed again in Step 3.

Compilation of Technical Dossier

Submission

Why EL-Science?

The primary difference between EL Science services and those of others offering TPD services is that we are specialist eLiquid scientists with our own eLiquid Analytical Laboratories and Flavour Laboratories on site.

We not only analyse the eLiquid but we provide the toxicological thresholds to work to and very importantly and uniquely, we then work with you to achieve those thresholds should your initial flavour not meet them. We enable you to meet the thresholds whilst maintaining your flavour profile through our Flavour Laboratory.

The primary requirements of the TPD Article 20 are summarised below:

Manufacturers and importers must submit a technical dossier to the relevant authorities (the MHRA in the UK) for each product.

A nicotine-containing liquid will have a maximum strength of 20 mg/mL.

Additives are highly restricted.

Refill bottles are limited to 10 mL, and pre-filled refill tanks and cartridges are limited to 2 mL.

Advertising is heavily restricted.

There are some restrictions on cross-border sales.

Retailers and manufacturers are required to share market data and trends with the competent authority.

Where sufficient robust data becomes available, member states may effectively ban individual products.

EL-Science Assistance with TPD Implementation

As specialists in the legislative and technical aspects required to meet the Tobacco Products Directive, we are able to assist with all aspects of TPD implementation from initial discussion and providing some clarity to the requirements through to providing a full technical dossier.

Speak to an expert about TPD implementation today

Technical Dossier

The TPD requires a Technical Dossier for every eLiquid flavour to be submitted to and approved by the Medical Health Regulatory Authority (MHRA) before the product can go on the market.

A key requirement of this dossier is a full Toxicological Risk Assessment (TRA) for that eLiquid flavour. Our team can compile and produce this TPD compliant Technical Dossier for your business.

Our services comprise of:

Analytical services

Compilation of toxicological data sets

Toxicological Risk Assessments

Final Technical Dossier compilation and submission

While the TPD requirements appear relatively straightforward and easy to meet, the primary concern stems from this requirement, and it is here that investment is primarily required. This Technical Dossier must:

Contain administrative information such as addresses, descriptions and declarations.

Detail the full chemical composition.

Provide a complete set of toxicological data for each chemical component.

Have an associated Toxicological Risk Assessment (TRA) prepared using the accumulated data for each end product.

eLiquids will undergo a full Toxicological Risk Assessment:

Stage One – Toxicological Determination

We work with specialist, fully registered toxicological companies to determine the toxicological profiles of over 300 individual chemical components, selected because they form the base components of the vast majority of flavour concentrates. Each chemical is individually assessed for potential adverse effects, and components of concern will be further investigated to achieve effective threshold limits.

Stage Two – Compositional Determination

The chemical composition of an eLiquid must be determined through a combination of supplier information and analytical determination and confirmation. Our dedicated eLiquid laboratory where we house high specification GC-MS, UPLC, Thermal Desorption, ICP-MS equipment and a whole range of smaller laboratory instrumentation which has been specifically chosen and commissioned to allow for chemical compositional analysis of eLiquid and eLiquid vapour.

Stage Three – Thermal Degradation Profiling

While no direct combustion occurs during the usage of ecigarettes, the atomiser coil may elevate temperatures to above 300 degrees celsius. At such high temperatures, certain chemicals can degrade. Thus, it is important to investigate these potential degradation pathways. This investigation work is then confirmed using our bespoke custom-built emissions equipment and GC-MS analysis within our Analytical Laboratories.

Stage Four – Toxicological Risk Assessment

Where appropriate, utilising the data generated in the previous stages, EL-Science performs a TPD compliant Toxicological Risk Assessment (TRA) for the specific eLiquid flavour for inclusion in your Technical Dossier. In this step, the Team compare the individual ingredients in the product and the concentration of those ingredients present against established Health Criteria Values (HCVs). HCVs are basically the tolerable threshold limits at which those ingredients can be present before they elicit unwanted or hazardous effects to human health.

Stage Five – Compilation and Submission

Our team of organic chemists are dedicated to understanding the toxicological data sets, thermal profiles and analyses for each eLiquid flavour. They ensure that each Technical Dossier is correctly compiled and compliant with submission requirements. Once the team is fully satisfied that the Technical Dossier contains all the required data they can submit the notification on your behalf, directly to the MHRA.